BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3180929 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-94883
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    April 23, 2013
    Report Date
    June 2, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. THE CALLER STATED THAT CURRENTLY HER GLUCOSE IS 497MG/DL, AND SHE HAS BEEN TREATED WITH MANUAL INJECTIONS. THE CALLER MENTIONED THAT THE INFUSION SETS AND RESERVOIRS HAVE EXPIRED. THE CALLER STATED THAT THE BATTERY HAS BEEN DEAD IN THE INSULIN PUMP FOR A FEW MONTHS, AND THE DEVICE ALARMED AFTER INSERTING A NEW BATTERY. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE CALLER STATED THAT THE CUSTOMER ACCIDENTALLY TOOK TOO MUCH INSULIN FOR HER DINNER, WHICH CAUSED HER BLOOD GLUCOSE TO DROP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280416 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization